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Analyses of 24-month data from the two pivotal phase III trials investigating a proprietary fluocinolone acetonide-releasing intravitreal insert for the treatment of diabetic macular edema generated positive results that are the basis of filing a new drug application with the FDA.
Miami-Analyses of 24-month data from the two pivotal phase III trials investigating a proprietary fluocinolone acetonide-releasing intravitreal insert (FA insert) (Iluvien, Alimera Sciences) for the treatment of diabetic macular edema (DME) generated positive results that are the basis for filing a new drug application (NDA) with the FDA, said Peter A. Campochiaro, MD, at Angiogenesis 2010.
Presented were the results based on all subjects who completed 24 months of follow-up in the two phase III clinical studies. More than three-fourths of the patients who received the FA insert had received only a single insert.
Numerically, efficacy was greater in both FA insert dose groups at month 24 compared with month 18, and analyses of secondary efficacy endpoints, including reduction in retinal thickness, other vision outcomes, and incidence of retinal laser treatment, also showed statistically significant superiority of the FA insert compared with control. Analyses based on a variety of other populations also supported the robustness of the findings in the Full Data Set analysis.
The incidence of corticosteroid-related adverse events was higher among patients in the high-dose versus low-dose FA insert group. An IOP increase of 30 mm Hg or more at any time point was recorded for 21.6% of patients with the low-dose insert and 16.3% of those with the high-dose inserts; rates of trabeculectomy were 5.1% in the high-dose group and only 2.1% in the low-dose group.
"The results are important, because they demonstrate that it is possible to provide controlled delivery of an agent to the retina for more than a year after a single injection in the clinic," Dr. Campochiaro said.
"They also demonstrate that the way one delivers steroids to the eye is critical," he added. "Steroid delivery at a very low dose over a long period of time provides benefits to patients with macular edema without the high rate of glaucoma seen with bolus injections or sustained delivery of higher doses."